Electronic submission for China drug registration applications will be available from January 1, 2023, onwards.
The National Medical Products Administration (NMPA) announced the implementation of electronic submission format for drug registration applications on November 30, 2022, whilst the Center for Drug Evaluation (CDE) issued a notice to address the requirements for electronic application for drug registrations on December 2, 2022.
Highlights
- Electronic submission of drug registration applications will be accepted by the Chinese regulator from January 1, 2023, onwards, by meeting the requirements of:
- Template format
- Document format
- Document name
- File size
- Page numbering
- File compression / encryption
- Electronic signature
- Disc format
- Applicants no longer need to submit the application dossiers in paper format.
- The new submission format of drug registration applications does not affect the existing working procedures.
Background information
Paper submission used to be the main method for drug registration in China. The CDE website first launched the electronic data submission column for applicants in 2012, and made improvements over the years by introducing the online drug master filing platform for active pharmaceutical ingredients (APIs), excipients and packaging materials where application dossiers were accepted in electronic format via CD-ROMs.
The online website was upgraded in 2019 to include a new function for filling in and submitting the application form online, however, the application dossiers for drug registrations were still only accepted in paper form.
On September 30, 2021, NMPA issued an announcement, requiring that from December 29, 2021, onwards, the application for marketing license of chemical drug registration category 1 and 5.1, as well as biological products for treatment and biological products for prevention can be filed according to eCTD. Other types of drugs and classifications for registration should still be implemented according to the previous requirements.
Due to the need for pandemic prevention and control, the CDE issued a new requirement for drug registration applicants in January 2022 to submit the application dossiers via electronic CD-ROMs first, and submit the hard copy version after the official review approval. Electronic payment for registration fees were also accepted.
Further information
Click here to read the NMPA announcement in full.
Click here to read the CDE announcement on submission requirements.
If you would like to know more about the electronic submission requirements, or if you need our support with the registration of your drug product in China, please contact us.
